Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-25 @ 2:32 PM
Study NCT ID:
NCT04375150
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2020-05-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Master Protocol to Study Treatment Patterns, Medication Adherence, Health and Economic Outcomes and Unmet Needs in RCC
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000092004', 'term': 'Tyrosine Kinase Inhibitors'}], 'ancestors': [{'id': 'D047428', 'term': 'Protein Kinase Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquires@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'For all-cause mortality: From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months. Data for non-serious adverse events and serious adverse events (SAEs) were not collected and evaluated during the study; hence timeframe is not applicable for non-SAEs and SAEs.', 'description': 'This observational retrospective study retrieved data from electronic medical records and claims and the data existed as structured data or combination of existing structured and unstructured data. In these data sources, individual participant data were not retrieved or validated, and it was not possible to link a particular product and medical event for any individual. Thus, the minimum criteria for reporting an adverse event could not be met, hence safety data were not collected and reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Axitinib + Pembrolizumab', 'description': 'Participants diagnosed with aRCC who initiated treatment with axitinib + pembrolizumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 340, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 161, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Axitinib + Avelumab', 'description': 'Participants diagnosed with aRCC initiated treatment with axitinib + avelumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 11, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With First Line Treatment Regimen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib + Pembrolizumab', 'description': 'Participants diagnosed with aRCC who initiated treatment with axitinib + pembrolizumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.'}, {'id': 'OG001', 'title': 'Axitinib + Avelumab', 'description': 'Participants diagnosed with aRCC initiated treatment with axitinib + avelumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '340', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At index (anytime between 1-Apr-2018 and 31-Jul-2022 [approximately 52 months]); data collected and observed retrospectively over 35 months', 'description': 'Number of participants with first line treatment regimen prescribed following a primary and secondary diagnosis of advanced/metastatic disease is reported in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants whose data were retrieved and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Monotherapy and Combination Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib + Pembrolizumab', 'description': 'Participants diagnosed with aRCC who initiated treatment with axitinib + pembrolizumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.'}, {'id': 'OG001', 'title': 'Axitinib + Avelumab', 'description': 'Participants diagnosed with aRCC initiated treatment with axitinib + avelumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.'}], 'classes': [{'title': 'Monotherapy- First Line', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Monotherapy- Second Line', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Monotherapy- Third Line', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Monotherapy- Fourth Line', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Monotherapy- Fifth Line', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Monotherapy- Sixth Line', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Combination therapy- First Line', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '340', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Combination therapy- Second Line', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Combination therapy- Third Line', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Combination therapy- Fourth Line', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Combination therapy- Fifth Line', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Combination therapy- Sixth Line', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months', 'description': 'Participants who received monotherapy and combination therapy by line of therapy is reported in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "All eligible participants whose data were retrieved and observed in this study. Here, 'Number Analyzed' signifies participants evaluable for specified rows."}, {'type': 'PRIMARY', 'title': 'Time to First Line Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib + Pembrolizumab', 'description': 'Participants diagnosed with aRCC who initiated treatment with axitinib + pembrolizumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.'}, {'id': 'OG001', 'title': 'Axitinib + Avelumab', 'description': 'Participants diagnosed with aRCC initiated treatment with axitinib + avelumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.00', 'groupId': 'OG000', 'lowerLimit': '18.00', 'upperLimit': '52.00'}, {'value': '25.00', 'groupId': 'OG001', 'lowerLimit': '20.00', 'upperLimit': '56.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From RCC diagnosis to index date (approximately 52 months); data collected and observed retrospectively over 35 months', 'description': 'Time to first line therapy was defined as length of time (days) from the first RCC diagnosis to first line therapy prescription. Index date was defined as the date of initiation of the aRCC treatment.', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants whose data were retrieved and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Duration of Treatment According to Each Line of Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib + Pembrolizumab', 'description': 'Participants diagnosed with aRCC who initiated treatment with axitinib + pembrolizumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.'}, {'id': 'OG001', 'title': 'Axitinib + Avelumab', 'description': 'Participants diagnosed with aRCC initiated treatment with axitinib + avelumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.'}], 'classes': [{'title': 'First Line Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.97', 'groupId': 'OG000', 'lowerLimit': '4.85', 'upperLimit': '22.05'}, {'value': '5.90', 'groupId': 'OG001', 'lowerLimit': '2.80', 'upperLimit': '16.27'}]}]}, {'title': 'Second Line Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.38', 'groupId': 'OG000', 'lowerLimit': '2.50', 'upperLimit': '11.70'}, {'value': '2.58', 'groupId': 'OG001', 'lowerLimit': '1.32', 'upperLimit': '4.03'}]}]}, {'title': 'Third Line Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.03', 'groupId': 'OG000', 'lowerLimit': '2.10', 'upperLimit': '7.03'}, {'value': '3.43', 'groupId': 'OG001', 'lowerLimit': '1.27', 'upperLimit': '11.33'}]}]}, {'title': 'Fourth Line Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.75', 'groupId': 'OG000', 'lowerLimit': '1.43', 'upperLimit': '6.07'}, {'value': '3.57', 'groupId': 'OG001', 'lowerLimit': '3.57', 'upperLimit': '3.57'}]}]}, {'title': 'Fifth Line Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.53', 'groupId': 'OG000', 'lowerLimit': '2.37', 'upperLimit': '3.93'}, {'value': '0.90', 'groupId': 'OG001', 'lowerLimit': '0.90', 'upperLimit': '0.90'}]}]}, {'title': 'Sixth Line Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.03', 'groupId': 'OG000', 'lowerLimit': '4.03', 'upperLimit': '4.03'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months', 'description': 'Duration of treatment as per each line of therapy is reported in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': "All eligible participants whose data were retrieved and observed in this study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows."}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment Continuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib + Pembrolizumab', 'description': 'Participants diagnosed with aRCC who initiated treatment with axitinib + pembrolizumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.'}, {'id': 'OG001', 'title': 'Axitinib + Avelumab', 'description': 'Participants diagnosed with aRCC initiated treatment with axitinib + avelumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months', 'description': 'Treatment continuation was considered when there was no more than (\\>) 30-day gap (i.e., persistent treatment) for the index medication during follow-up period. Index date was defined as the date of initiation of the aRCC treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants whose data were retrieved and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment Interruption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib + Pembrolizumab', 'description': 'Participants diagnosed with aRCC who initiated treatment with axitinib + pembrolizumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.'}, {'id': 'OG001', 'title': 'Axitinib + Avelumab', 'description': 'Participants diagnosed with aRCC initiated treatment with axitinib + avelumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '171', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months', 'description': 'Treatment Interruption was considered in participants with gaps in treatment greater than allowable gap but who restart the same medication with no indication of switching or augmentation. Index date was defined as the date of initiation of the aRCC treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants whose data were retrieved and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Time to Treatment Interruption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib + Pembrolizumab', 'description': 'Participants diagnosed with aRCC who initiated treatment with axitinib + pembrolizumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.'}, {'id': 'OG001', 'title': 'Axitinib + Avelumab', 'description': 'Participants diagnosed with aRCC initiated treatment with axitinib + avelumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.10', 'groupId': 'OG000', 'lowerLimit': '0.70', 'upperLimit': '4.20'}, {'value': '1.05', 'groupId': 'OG001', 'lowerLimit': '0.43', 'upperLimit': '2.55'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months', 'description': 'Time from index medication to treatment discontinuation for those within treatment interruptions (\\>30 day gaps). Represents the time between index and end of last treatment, including any treatment gaps. Index date was defined as the date of initiation of the aRCC treatment.', 'unitOfMeasure': 'Months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': "All eligible participants whose data were retrieved and observed in this study. Here, 'Overall Number of Participants Analyzed' signified participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment Switch or Augmentation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib + Pembrolizumab', 'description': 'Participants diagnosed with aRCC who initiated treatment with axitinib + pembrolizumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.'}, {'id': 'OG001', 'title': 'Axitinib + Avelumab', 'description': 'Participants diagnosed with aRCC initiated treatment with axitinib + avelumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.'}], 'classes': [{'title': 'Treatment Switch', 'categories': [{'measurements': [{'value': '146', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Treatment Augmentation', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months', 'description': 'Number of participants who had treatment switch or augmentation were reported in this outcome measure. Augmentation was defined as addition of treatment to initial therapy prescribed, i.e, initiation of a new therapy different from the initial therapy while continuation of the initial therapy. Index date was defined as the date of initiation of the aRCC treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants whose data were retrieved and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants According to Lines of Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib + Pembrolizumab', 'description': 'Participants diagnosed with aRCC who initiated treatment with axitinib + pembrolizumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.'}, {'id': 'OG001', 'title': 'Axitinib + Avelumab', 'description': 'Participants diagnosed with aRCC initiated treatment with axitinib + avelumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.'}], 'classes': [{'title': 'First Line Therapy', 'categories': [{'measurements': [{'value': '340', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Second Line Therapy', 'categories': [{'measurements': [{'value': '148', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Third Line Therapy', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Fourth Line Therapy', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Fifth Line Therapy', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Sixth Line Therapy', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months', 'description': 'Number of participants as per the lines of treatment were reported in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants whose data were retrieved and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib + Pembrolizumab', 'description': 'Participants diagnosed with aRCC who initiated treatment with axitinib + pembrolizumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.'}, {'id': 'OG001', 'title': 'Axitinib + Avelumab', 'description': 'Participants diagnosed with aRCC initiated treatment with axitinib + avelumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.'}], 'classes': [{'title': 'Avelumab,Axitinib', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Avelumab, Axitinib/ Axitinib, Pembrolizumab', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Avelumab, Axitinib/ Cabozantinib', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Avelumab,Axitinib/ Cabozantinib/ Cabozantinib, Nivolumab/ Tivozanib/ Pazopanib', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Avelumab,Axitinib/ Cabozantinib/ Everolimus, Lenvatinib', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Avelumab,Axitinib/ Cabozantinib/ Pazopanib', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Avelumab, Axitinib/ Ipilimumab, Nivolumab', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Avelumab, Axitinib/ Nivolumab', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Avelumab, Axitinib/ Pembrolizumab', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Axitinib,Pembrolizumab', 'categories': [{'measurements': [{'value': '192', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Axitinib,Pembrolizumab/ Axitinib (PEM-AXI), leuprolide, Pembrolizumab', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI,PEM/ AXI,Leuprolide,PEM/ Abiraterone,AXI,PEM/Abiraterone,Axitinib,Leuprolide, PEM', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ AXI, PEM/ Cabozantinib', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Bevacizumab/ Cabozantinib', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Bevacizumab- Awwb/ Bevacizumab/ Temsirolimus/ Bevacizumab- Awwb', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Bevacizumab-Awwb/ Cabozantinib', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Bevacizumab-Awwb, Everolimus', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Cabozantinib', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Cabozantinib/Bevacizumab- Awwb', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Cabozantinib/Cabozantinib, Nivolumab', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Cabozantinib/ Cabozantinib, PEM/ Everolimus, Lenvatinib', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Cabozantinib/ Clinical Study Drug (CSD)/ Everolimus, Lenvatinib/ Belzutifan', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Cabozantinib/ Everolimus, Lenvatinib', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Cabozantinib/ Everolimus, Lenvatinib/ Bevacizumab -Bvzr, Erlotinib', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Cabozantinib/ Everolimus, Lenvatinib/ CSD', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Cabozantinib/ Everolimus,Lenvatinib/ Ipilimumab, Nivolumab', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Cabozantinib/ Everolimus, Lenvatinib, Tivozanib', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Cabozantinib/ Ipilimumab, Nivolumab', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Cabozantinib/ Ipilimumab, Nivolumab/ Everolimus, Lenvatinib', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Cabozantinib/ Pazopanib/ Ipilimumab, Nivolumab', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Cabozantinib/ Pazopanib- Lenvatinib, Pembrolizumab/ Tivozanib', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Cabozantinib/Tivozanib/ Ipilimumab, Nivolumab', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Cabozantinib,CSD', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Cabozantinib,Nivolumab', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Cabozantinib,Nivolumab/ Everolimus,Lenvatinib', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Cabozantinib,Nivolumab,PEM/ Everolimus,Lenvatinib', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Cabozantinib,PEM', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/Chlorambucil,Obinutuzumab/ Rituximab', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ CSD', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ CSD/ Cabozantinib', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI,PEM/ CSD,Cyclophosphamide,Daratumumab/Hyaluronidase- Fihj,Fludarabine/ Cabozantinib,Nivolumab', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ CSD,Cyclophosphamide,Fludarabine/ Cabozantinib,Nivolumab', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Axitinib,Pembrolizumab/CSD,Gemcitabine', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM-Doxorubicin,PEM/ Cabozantinib', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Everolimus', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Everolimus/ Pazopanib', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Everolimus,Lenvatinib', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Everolimus,Lenvatinib/ Cabozantinib/ Everolimus', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Everolimus,Lenvatinib/ Cabozantinib,Nivolumab', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Everolimus,Lenvatinib/ Ipilimumab,Nivolumab', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Everolimus,Lenvatinib,Pembrolizumab', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Gemcitabine,Paclitaxel Protein-Bound,Pembrolizumab', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Hydroxyurea,Pembrolizumab', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Ipilimumab,Nivolumab', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Ipilimumab,Nivolumab/ Cabozantinib', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Ipilimumab,Nivolumab/ Cabozantinib,Ipilimumab,Nivolumab', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Axitinib,Pembrolizumab/ Ipilimumab,Nivolumab/ CSD', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Ipilimumab,Nivolumab/ Everolimus,Lenvatinib', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Lenvatinib', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Lenvatinib, Pembrolizumab', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Leuprolide/ Bicalutamide,Leuprolide', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Nivolumab/ Cabozantinib', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Nivolumab/ Cabozantinib,Nivolumab', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Pazopanib', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Pazopanib/ Cabozantinib/ Everolimus,Lenvatinib/ Sunitinib/ Tivozanib', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Pazopanib/ Cabozantinib,Nivolumab', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Pazopanib/ Everolimus,Lenvatinib', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ PEM', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ PEM,Sunitinib', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Sunitinib/ Pembrolizumab,Sunitinib', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AXI, PEM/ Sunitinib/Tivozanib/ Cabozantinib/ Tivozanib', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months', 'description': 'Number of participants according to the sequence of therapies received for mRCC were reported in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants whose data were retrieved and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Number of Participants According to Their Status at End of Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib + Pembrolizumab', 'description': 'Participants diagnosed with aRCC who initiated treatment with axitinib + pembrolizumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.'}, {'id': 'OG001', 'title': 'Axitinib + Avelumab', 'description': 'Participants diagnosed with aRCC initiated treatment with axitinib + avelumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.'}], 'classes': [{'title': 'Death', 'categories': [{'measurements': [{'value': '161', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'End of enrollment', 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'End of data availability', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At end of enrollment, follow-up or death (maximum of 52 months) (data collected and observed retrospectively over 35 months)', 'description': 'Number of participants according to their status (death, end of enrollment and end of data availability) at end of follow-up were observed and included in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants whose data were retrieved and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Time to Treatment Failure (TTF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib + Pembrolizumab', 'description': 'Participants diagnosed with aRCC who initiated treatment with axitinib + pembrolizumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.'}, {'id': 'OG001', 'title': 'Axitinib + Avelumab', 'description': 'Participants diagnosed with aRCC initiated treatment with axitinib + avelumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.57', 'groupId': 'OG000', 'lowerLimit': '2.10', 'upperLimit': '2.90'}, {'value': '1.83', 'groupId': 'OG001', 'lowerLimit': '0.93', 'upperLimit': '4.37'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months', 'description': 'TTF was defined as the time from first-line therapy start to treatment discontinuation for any reason, including switched, augmented therapy, end of enrollment or death. Index date was defined as the date of initiation of the aRCC treatment.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants whose data were retrieved and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Treatment Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib + Pembrolizumab', 'description': 'Participants diagnosed with aRCC who initiated treatment with axitinib + pembrolizumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.'}, {'id': 'OG001', 'title': 'Axitinib + Avelumab', 'description': 'Participants diagnosed with aRCC initiated treatment with axitinib + avelumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months', 'description': 'Percentage of participants with treatment discontinuation was defined as the percentage of participants with gap in therapy greater than 30 days and who did not begin a new treatment. Index date was defined as the date of initiation of the aRCC treatment.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants whose data were retrieved and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Alive at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib + Pembrolizumab', 'description': 'Participants diagnosed with aRCC who initiated treatment with axitinib + pembrolizumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.'}, {'id': 'OG001', 'title': 'Axitinib + Avelumab', 'description': 'Participants diagnosed with aRCC initiated treatment with axitinib + avelumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '90.29', 'groupId': 'OG000'}, {'value': '86.67', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 3 months (data collected and observed retrospectively over 35 months)', 'description': 'Percentage of participants who were alive at 3 months is reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants whose data were retrieved and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Alive at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib + Pembrolizumab', 'description': 'Participants diagnosed with aRCC who initiated treatment with axitinib + pembrolizumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.'}, {'id': 'OG001', 'title': 'Axitinib + Avelumab', 'description': 'Participants diagnosed with aRCC initiated treatment with axitinib + avelumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '82.35', 'groupId': 'OG000'}, {'value': '66.67', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 3 months (data collected and observed retrospectively over 35 months)', 'description': 'Percentage of participants who were alive at 6 months is reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants whose data were retrieved and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Alive at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib + Pembrolizumab', 'description': 'Participants diagnosed with aRCC who initiated treatment with axitinib + pembrolizumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.'}, {'id': 'OG001', 'title': 'Axitinib + Avelumab', 'description': 'Participants diagnosed with aRCC initiated treatment with axitinib + avelumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '67.35', 'groupId': 'OG000'}, {'value': '40.00', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 3 months (data collected and observed retrospectively over 35 months)', 'description': 'Percentage of participants who were alive at 12 months is reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants whose data were retrieved and observed in this study.'}, {'type': 'PRIMARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib + Pembrolizumab', 'description': 'Participants diagnosed with aRCC who initiated treatment with axitinib + pembrolizumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.'}, {'id': 'OG001', 'title': 'Axitinib + Avelumab', 'description': 'Participants diagnosed with aRCC initiated treatment with axitinib + avelumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.43', 'groupId': 'OG000', 'lowerLimit': '24.17', 'upperLimit': '37.53'}, {'value': '11.97', 'groupId': 'OG001', 'lowerLimit': '4.83', 'upperLimit': '28.47'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months', 'description': "OS is defined as the length of time from index date to participant's death. Index date was defined as the date of initiation of the aRCC treatment.", 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants whose data were retrieved and observed in this study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Axitinib + Pembrolizumab', 'description': 'Participants diagnosed with aRCC who initiated treatment with axitinib + pembrolizumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.'}, {'id': 'FG001', 'title': 'Axitinib + Avelumab', 'description': 'Participants diagnosed with aRCC initiated treatment with axitinib + avelumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '340'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '340'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants diagnosed with advanced/metastatic renal cell carcinoma (RCC) who initiated treatment for aRCC between 1-Apr-2018 and 31-Jul-2022 were observed. Data was collected retrospectively from various real world claims databases (Truven, Optum, Pharmetrics and the PanTher). Index date was the date of initiation of the aRCC treatment. Data was collected and observed for approximately 35 months (02 December 2019 to 28 October 2022) of this study.', 'preAssignmentDetails': 'A total of 355 participants were included in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '355', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Axitinib + Pembrolizumab', 'description': 'Participants diagnosed with aRCC who initiated treatment with axitinib + pembrolizumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.'}, {'id': 'BG001', 'title': 'Axitinib + Avelumab', 'description': 'Participants diagnosed with aRCC initiated treatment with axitinib + avelumab between 1-Apr-2018 and 31-Jul-2022 were included and observed retrospectively in this study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.13', 'spread': '10.93', 'groupId': 'BG000'}, {'value': '66.87', 'spread': '10.45', 'groupId': 'BG001'}, {'value': '64.25', 'spread': '10.91', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '235', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '247', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '237', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '245', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '228', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '239', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis population included all eligible participants whose data were retrieved and observed in this study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-12-01', 'size': 2378900, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-10-17T13:42', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 355}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-14', 'studyFirstSubmitDate': '2020-05-01', 'resultsFirstSubmitDate': '2023-10-17', 'studyFirstSubmitQcDate': '2020-05-01', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-14', 'studyFirstPostDateStruct': {'date': '2020-05-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With First Line Treatment Regimen', 'timeFrame': 'At index (anytime between 1-Apr-2018 and 31-Jul-2022 [approximately 52 months]); data collected and observed retrospectively over 35 months', 'description': 'Number of participants with first line treatment regimen prescribed following a primary and secondary diagnosis of advanced/metastatic disease is reported in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.'}, {'measure': 'Number of Participants With Monotherapy and Combination Therapy', 'timeFrame': 'From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months', 'description': 'Participants who received monotherapy and combination therapy by line of therapy is reported in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.'}, {'measure': 'Time to First Line Therapy', 'timeFrame': 'From RCC diagnosis to index date (approximately 52 months); data collected and observed retrospectively over 35 months', 'description': 'Time to first line therapy was defined as length of time (days) from the first RCC diagnosis to first line therapy prescription. Index date was defined as the date of initiation of the aRCC treatment.'}, {'measure': 'Duration of Treatment According to Each Line of Therapy', 'timeFrame': 'From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months', 'description': 'Duration of treatment as per each line of therapy is reported in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.'}, {'measure': 'Number of Participants With Treatment Continuation', 'timeFrame': 'From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months', 'description': 'Treatment continuation was considered when there was no more than (\\>) 30-day gap (i.e., persistent treatment) for the index medication during follow-up period. Index date was defined as the date of initiation of the aRCC treatment.'}, {'measure': 'Number of Participants With Treatment Interruption', 'timeFrame': 'From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months', 'description': 'Treatment Interruption was considered in participants with gaps in treatment greater than allowable gap but who restart the same medication with no indication of switching or augmentation. Index date was defined as the date of initiation of the aRCC treatment.'}, {'measure': 'Time to Treatment Interruption', 'timeFrame': 'From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months', 'description': 'Time from index medication to treatment discontinuation for those within treatment interruptions (\\>30 day gaps). Represents the time between index and end of last treatment, including any treatment gaps. Index date was defined as the date of initiation of the aRCC treatment.'}, {'measure': 'Number of Participants With Treatment Switch or Augmentation', 'timeFrame': 'From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months', 'description': 'Number of participants who had treatment switch or augmentation were reported in this outcome measure. Augmentation was defined as addition of treatment to initial therapy prescribed, i.e, initiation of a new therapy different from the initial therapy while continuation of the initial therapy. Index date was defined as the date of initiation of the aRCC treatment.'}, {'measure': 'Number of Participants According to Lines of Therapy', 'timeFrame': 'From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months', 'description': 'Number of participants as per the lines of treatment were reported in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.'}, {'measure': 'Number of Participants According to Sequence of Therapies for Metastatic Renal Cell Carcinoma (mRCC)', 'timeFrame': 'From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months', 'description': 'Number of participants according to the sequence of therapies received for mRCC were reported in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.'}, {'measure': 'Number of Participants According to Their Status at End of Follow-up', 'timeFrame': 'At end of enrollment, follow-up or death (maximum of 52 months) (data collected and observed retrospectively over 35 months)', 'description': 'Number of participants according to their status (death, end of enrollment and end of data availability) at end of follow-up were observed and included in this outcome measure. Index date was defined as the date of initiation of the aRCC treatment.'}, {'measure': 'Time to Treatment Failure (TTF)', 'timeFrame': 'From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months', 'description': 'TTF was defined as the time from first-line therapy start to treatment discontinuation for any reason, including switched, augmented therapy, end of enrollment or death. Index date was defined as the date of initiation of the aRCC treatment.'}, {'measure': 'Percentage of Participants With Treatment Discontinuation', 'timeFrame': 'From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months', 'description': 'Percentage of participants with treatment discontinuation was defined as the percentage of participants with gap in therapy greater than 30 days and who did not begin a new treatment. Index date was defined as the date of initiation of the aRCC treatment.'}, {'measure': 'Percentage of Participants Alive at 3 Months', 'timeFrame': 'At 3 months (data collected and observed retrospectively over 35 months)', 'description': 'Percentage of participants who were alive at 3 months is reported in this outcome measure.'}, {'measure': 'Percentage of Participants Alive at 6 Months', 'timeFrame': 'At 3 months (data collected and observed retrospectively over 35 months)', 'description': 'Percentage of participants who were alive at 6 months is reported in this outcome measure.'}, {'measure': 'Percentage of Participants Alive at 12 Months', 'timeFrame': 'At 3 months (data collected and observed retrospectively over 35 months)', 'description': 'Percentage of participants who were alive at 12 months is reported in this outcome measure.'}, {'measure': 'Overall Survival', 'timeFrame': 'From the index date until end of enrollment, follow-up or death (maximum of 52 months); data collected and observed retrospectively over 35 months', 'description': "OS is defined as the length of time from index date to participant's death. Index date was defined as the date of initiation of the aRCC treatment."}]}, 'oversightModule': {'isFdaRegulatedDrug': True}, 'conditionsModule': {'conditions': ['Renal Cell Carcinoma (RCC)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=A6181232', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The study aims to assess treatment patterns and outcomes in advanced RCC patients in real world clinical practices across various real world databases. Four databases will be evaluated'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with RCC', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 20 years or older in the year of the index first line therapy prescription.\n\n * 2 or more RCC diagnoses (ICD-9: 189.0; ICD-10: C64.1, C64.2, C64.9) at least 30 days apart, in the 1 year prior to the index date until 30 days post index date.\n * 2 or more code for secondary malignancy codes indicating possible diagnoses for metastatic disease at least 30 days apart, in the 1 year prior to the index date until 30 days post index date. (ICD-9: xx-199.xx; ICD-10: C77-C79, except ICD9: 198.0 Secondary malignant neoplasm of the kidney and ICD10: C79.0 Secondary malignant neoplasm of the kidney and renal pelvis.)\n * Exploratory sensitivity analyses were performed to review patients with 1 or more diagnosis codes for advanced or metastatic RCC 12 months prior to the index date and 1 or more secondary malignancy codes around the RCC diagnosis dates.\n * Continuous enrollment from 12 months prior to the index date. Patients will be required to have continuous enrollment from their index date until the end of the available data. This will allow for sub-analysis of cohorts with 3 months, 6 months and 12 months of available data\n\nExclusion Criteria:\n\n* Received advanced treatment prior to the study index date.\n\n * Prescription records with negative days of supply will be excluded from all the analyses except in cost variable calculation. The day of supply for claims with missing or 0 days will be imputed.\n * Only one RCC diagnosis in the 12 months prior or one mont post index date.\n * Patients with data for analysis (\\< 3 months post index date)'}, 'identificationModule': {'nctId': 'NCT04375150', 'briefTitle': 'Master Protocol to Study Treatment Patterns, Medication Adherence, Health and Economic Outcomes and Unmet Needs in RCC', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Study of Advanced Renal Cell Carcinoma Treatment Patterns and Unmet Needs Using Real World Claims and Electronic Medical Record Data.', 'orgStudyIdInfo': {'id': 'A6181232'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with advanced renal cell carcinoma (RCC)', 'interventionNames': ['Drug: Tyrosine kinase inhibitor (TKI)', 'Drug: Immuno-oncology (IO)']}], 'interventions': [{'name': 'Tyrosine kinase inhibitor (TKI)', 'type': 'DRUG', 'description': 'TKIs', 'armGroupLabels': ['Patients with advanced renal cell carcinoma (RCC)']}, {'name': 'Immuno-oncology (IO)', 'type': 'DRUG', 'description': 'IOs', 'armGroupLabels': ['Patients with advanced renal cell carcinoma (RCC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10017', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer INC', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}